An Investigation of the Effects of Manual Therapy on the Spatiotemporal Gait Characteristics in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Spatiotemporal Gait Characteristics (Gait Analysis)
研究概览
简要总结
The primary aim of this study is to investigate the effects of manual therapy on spatiotemporal characteristics of gait and gait variability, functional exercise capacity, and pulmonary function in patients with chronic obstructive pulmonary disease (COPD).
The secondary aims of the study are to determine the effects of manual therapy on balance, respiratory muscle strength, quality of life, physical activity, symptom severity, accessory respiratory muscle activation, peripheral muscle strength, chest wall mobility, dysfunctional breathing, pain, and posture.
详细描述
Musculoskeletal changes secondary to systemic inflammation in chronic obstructive pulmonary disease (COPD) negatively affect both ventilatory efficiency and ventilation-perfusion matching during walking, leading to a reduction in functional capacity. Current and conventional pulmonary rehabilitation approaches generally aim to improve aerobic capacity, muscle strength, and respiratory muscle endurance. However, aspects such as thoracic spine mobility, costotransverse and costovertebral joint biomechanics, the craniocaudal positioning of the diaphragm, and accessory respiratory muscle activation are still not adequately addressed in existing rehabilitation programs. The effects of manual therapy applied to the thoracic region, trunk, and accessory respiratory muscles on both exercise capacity and the spatiotemporal characteristics of gait have not yet been clearly established. Given the multisystem involvement in COPD, the application of manual therapy-an intervention with a high level of evidence in the management of other musculoskeletal conditions-offers an innovative approach to treatment. It is plausible that muscle energy techniques, one of the manual therapy methods, may reduce hypertonicity in excessively activated accessory respiratory muscles during breathing and thereby enhance chest wall expansion. In the existing literature, the limited number of studies investigating manual therapy interventions in COPD have primarily focused on pulmonary function and exercise capacity; however, there is still no consensus regarding the outcomes. Considering the biomechanical connection between the thoracic cage and the trunk and extremities, it can be hypothesized that manual therapies in COPD may influence gait by affecting lower extremity movements. In this context, manual therapy may impact not only respiratory parameters but also gait performance through the interaction between biomechanics, respiration, and posture in patients with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The all participants will be blinded. The outcome assessor who will participate in the gait analysis, balance assessment, and EMG analysis will blind to participant allocation. Participants will be randomized into the intervention and control groups using a computer-based randomization sequence with a 1:1 allocation ratio. Allocation concealment will be ensured using sequentially numbered, sealed, and opaque envelopes.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Clinically stable for at least the past 4 weeks
- •Classified as GOLD stage 1, 2, or 3 according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) airflow limitation classification
- •Classified as group A, B, or E according to the GOLD ABE assessment tool
排除标准
- •Use of walking assistive devices
- •Receiving long-term oxygen therapy
- •Presence of additional orthopedic, neuromuscular, neurological, or cardiac conditions that may affect gait and balance
- •History of lung cancer, sarcoidosis, tuberculosis, and/or lung surgery
- •Presence of musculoskeletal conditions such as fibromyalgia, rheumatoid arthritis, or osteoarthritis
- •Presence of a known mental or cognitive impairment
研究组 & 干预措施
Manual therapy Group
Muscle energy techniques and diaphragmatic relaxation techniques
干预措施: Manual therapy Group (Other)
Control Group
Respiratory exercises and stretching exercises Stretching will be applied to the following muscle groups: pectoralis major and minor, upper trapezius, scalene muscles, sternocleidomastoid, and latissimus dorsi.
干预措施: Control group (Other)
结局指标
主要结局
Spatiotemporal Gait Characteristics (Gait Analysis)
时间窗: At the baseline and after the eight-week intervention
The spatiotemporal characteristics of gait and gait variability will be assessed using an electronic walkway system (GAITRite, CIR Systems Inc., Franklin, New Jersey, USA). GAITRite is a system with established reliability and validity for gait assessment in individuals with COPD. Data will be collected at the beginning and at the end of a six-minute walking period. Participants will walk at their self-selected pace. Gait data obtained at the beginning and at the end of the six-minute walk will be averaged for data analysis. Data normalization will be performed using participants' leg length (cm), height (cm), or body weight (kg) values.
Spatial Gait Distance Parameters
时间窗: At the baseline and after the eight-week intervention
Mean step length, stride length, and step width measured using the GAITRite electronic walkway system. Unit of Measure: meters (m)
Temporal Gait Parameters
时间窗: At the baseline and after the eight-week intervention
Mean stance phase duration, swing phase duration, stride time, and step time assessed using GAITRite. Unit of Measure: seconds (s)
Gait Speed
时间窗: At the baseline and after the eight-week intervention
Mean walking speed measured using the GAITRite system during self-selected pace walking. Unit of Measure: meters per second (m/s)
Cadence
时间窗: At the baseline and after the eight-week intervention
Mean cadence assessed using GAITRite during the six-minute walk test. Unit of Measure: steps per minute (steps/min)
Gait Symmetry and Asymmetry Indices
时间窗: At the baseline and after the eight-week intervention
Right-left gait symmetry and asymmetry indices derived from spatiotemporal gait parameters. Unit of Measure: ratio or percentage (%)
Gait Variability Parameters
时间窗: At the baseline and after the eight-week intervention
Stride time variability, step time variability, and step width variability calculated from GAITRite data. Unit of Measure: coefficient of variation (%)
Functional exercise capacity
时间窗: At the baseline and after the eight-week intervention
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT). The test will be conducted in accordance with the criteria of the American Thoracic Society (ATS). Heart rate and peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter (Nonin Model 2500C, Nonin Medical, Inc., Plymouth, Minnesota, USA), and blood pressure will be measured using a sphygmomanometer (Erka Perfect Aneroid, Berlin, Germany) before the test, at the first minute, and immediately after the test. Leg fatigue, general fatigue, and dyspnea will be assessed using the Modified Borg Scale. At the end of the test, the total distance walked will be recorded in meters. Predicted values based on age, sex, height, and body weight will be used to calculate the percentage of the predicted walking distance achieved by each participant. To evaluate mechanical workload, the 6MWT workload will be calculated by multiplying the six-minute walking distance by the participant's body weight.
Pulmonary Functions
时间窗: At baseline and after the eight-week intervention
Pulmonary functions will be assessed using spirometry in accordance with the guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Forced expiratory volume in one second (FEV₁) will be recorded. FEV₁ expressed as a percentage of predicted values based on reference equations. Unit of Measure: Percentage (%) Based on spirometry results, airflow limitation in COPD will be classified according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) criteria, with FEV₁/FVC \< 0.70 defined for all groups. Classification will be as follows: * GOLD 1 (Mild): FEV₁ ≥ 80% of predicted * GOLD 2 (Moderate): 50% ≤ FEV₁ \< 80% of predicted * GOLD 3 (Severe): 30% ≤ FEV₁ \< 50% of predicted * GOLD 4 (Very severe): FEV₁ \< 30% of predicted
Forced Vital Capacity (FVC)
时间窗: At the baseline and after the eight-week intervention
Forced vital capacity (FVC) measured by spirometry following ATS/ERS standards. Unit of Measure: Liters (L) an persantage (%)
FEV₁/FVC Ratio
时间窗: At the baseline and after the eight-week intervention
The ratio of forced expiratory volume in one second to forced vital capacity (FEV₁/FVC) obtained from spirometry. Unit of Measure: Ratio
Peak Expiratory Flow (PEF)
时间窗: At the baseline and after the eight-week intervention
Peak expiratory flow assessed by spirometry according to ATS/ERS guidelines. Unit of Measure: Liters per second (L/s) and persentage (%)
Forced Expiratory Flow 25-75% (FEF₂₅-₇₅)
时间窗: At the baseline and after the eight-week intervention
Forced expiratory flow between 25% and 75% of forced vital capacity measured using spirometry. Unit of Measure: Liters per second (L/s) and persentage
次要结局
- Respiratory muscle strength(At the baseline and after the eight-week intervention)
- Peripheral muscle strength(At the baseline and after the eight-week intervention)
- Balance assessment(At the baseline and after the eight-week intervention)
- Accessory Muscle activation(At the baseline and after the eight-week intervention)
- Posture(At the baseline and after the eight-week intervention)
- Chest wall assessment(At the baseline and after the eight-week intervention)
- Dyspnea Level(At the baseline and after the eight-week intervention)
- Severity of symptoms(At the baseline and after the eight-week intervention)
- Severity of disease(At the baseline and after the eight-week intervention)
- Severity of disease and mortality(At the baseline and after the eight-week intervention)
- Quality of life (St. George's Respiratory Questionnaire )(At the baseline and after the eight-week intervention)
- Physical Activity (International Physical Activity Questionnaire)(At the baseline and after the eight-week intervention)
- Dysfunctional breathing (The Nijmegen Questionnaire)(At the baseline and after the eight-week intervention)
- Pain Level (Visual Analog Scale)(At the baseline and after the eight-week intervention)
研究者
Aynur Demirel
PT, PhD, Assoc. Prof.
Hacettepe University